InterHill MED Completes First-in-China Clinical Implantation of LomaPulse® Pulsed Field Ablation System for Atrial Fibrillation
June 16, 2022Zhouling (Shanghai) Medical Device Co., Ltd.（(abbreviated as Zhouling Medical)Independent R&DofLomaPulse®Pulsed Electric FieldDisappearanceRongProductThe first clinical application in China was completed at the Third Xiangya Hospital of Central South University.
The procedure was performed under the leadership of Professor Zhang Zhihui, Director of the Atrial Fibrillation Center at the Third Xiangya Hospital of Central South University; Dr. Huang, a renowned American cardiologist and electrophysiologist; and Dr. Xu Tao, Chief Scientist of Electronic Science and Technology at Zhouling Medical. The successful completion of this procedure signifies thatLomaPulse®Pulsed Electric FieldEliminationRongProductOne step closer to market approval.
(LomaPulse® Pulsed Electric FieldXiao(The physician team that conducted the first clinical enrollment for the financial product)
According to reports, the first patient enrolled in the clinical trial was a 60-year-old female with paroxysmal atrial fibrillation. Professor Zhang Zhihui’s team utilized LomaPulse®, a pulsed field ablation product independently developed by Zhouling Medical, for this patient.
During the surgery, Professor Zhang Zhihui firstUsageLomaPulse®Mapping electrodes map the patient's intracardiac electrocardiographic signals, followed by the use ofLomaPulse®The pulsed ablation catheter performed pulsed ablation on the patient's left superior pulmonary vein (LSPV), left inferior pulmonary vein (LIPV), right superior pulmonary vein (RSPV), and right inferior pulmonary vein (RIPV), respectively.Pulmonary vein isolation was successfully achieved in just approximately 50 seconds.Finally,Professor Zhang Zhihui's TeamUseCS S1S1 (S1S2) Pacing stimulation cannot induce atrial fibrillation.
Verification results showed that immediate isolation of the patient’s left and right pulmonary veins was successfully achieved. Traditional cryoablation or radiofrequency ablation not only requires prolonged procedural time but also carries a higher risk of injuring nerves and esophageal tissue, potentially leading to complications such as pulmonary vein stenosis. The use of the pulsed field ablation device in this case significantly reduced the procedure time, whileAchieved Selective Ablation of Cardiomyocytes，maintained the integrity of the tissue matrix, notdamages surrounding tissues, thereby improving the efficiency and success rate of ablation procedures.
Atrial Fibrillation, abbreviated as AFib, is the most common type of rapid arrhythmia. Data indicates that atrial fibrillation refers to the transformation of regular and organized atrial electrical activity into rapid and disorganized activity, typically manifesting as an irregular and often rapid heart rate.
In May 2022, the study “Prevalence and Risks of Atrial Fibrillation in China: A Nationwide Cross-Sectional Epidemiological Study,” published in a Lancet subsidiary journal, showed that:The standardized prevalence of atrial fibrillation (AF) among adults in China is 1.6%, with 43.8% being newly diagnosed cases. Based on data from the Sixth National Population Census, the age-standardized prevalence of AF in China is 1.6%, with an estimated 20 million affected individuals.。
Clinically, patients with atrial fibrillation often experience symptoms such as palpitations, dizziness, chest tightness, and fatigue; they may also present with amaurosis fugax or even syncope, which significantly impair their quality of life. More importantly, atrial fibrillation predisposes patients to stroke and heart failure, conditions associated with high mortality and disability rates.
It can be said that atrial fibrillation has become a major cardiovascular disease posing a significant threat to human health. However, current treatment modalities for atrial fibrillation all have certain limitations.
For example, pharmacological therapy cannot provide a radical cure for atrial fibrillation; the surgical Maze procedure is highly invasive and associated with a high incidence of postoperative complications such as bleeding; cardiac radiofrequency ablation and cryoablation lack tissue selectivity and may cause damage to surrounding normal tissues, including the esophagus and phrenic nerve. Furthermore, surgical interventions are associated with a certain rate of recurrence.
To address these clinical pain points, Zhouling Medical has developed a pulsed field ablation product based on pulsed electric field technology.
From a mechanistic perspective, radiofrequency ablation utilizes radiofrequency current to generate thermal effects in pathological tissue, leading to progressive dehydration, denaturation of cellular proteins, and coagulative necrosis, thereby providing a curative treatment for arrhythmias (atrial fibrillation). Cryoablation leverages the endothermic effect of refrigerant evaporation to extract heat from pathological tissue, lowering the temperature at the target site and blocking electrical signal conduction in specific cardiac regions, thus treating arrhythmias (atrial fibrillation).
Consistent with the principles of radiofrequency ablation and cryoablation for treating atrial fibrillation, pulsed field ablation also works by “killing” the corresponding diseased cells, thereby restoring normal and orderly electrical activity in the atria. However, unlike thermal effects or evaporative cooling, pulsed field ablation technology is based on the mechanism of irreversible electroporation.
Data indicate that irreversible electroporation refers to the process whereby, under a specific electric field intensity, the cell membrane becomes permanently permeable, leading to leakage of cellular contents and subsequent cell death. It should be noted thatThe irreversible electroporation effect of pulsed electric fields is tissue-selective; that is, at a specific pulsed electric field intensity, only certain tissues undergo irreversible electroporation, while other tissues remain unaffected.。
Leveraging the tissue selectivity of pulsed electric field technology, pulsed field ablation products offer significant advantages in the treatment of atrial fibrillation.Specifically, radiofrequency ablation and cryoablation are prone to causing damage to normal tissues surrounding the lesion site, whereas pulsed field ablation products offer tissue selectivity and do not affect normal tissues such as endothelial cells, nerve cells, and smooth muscle around the lesion.。
Zhouling Medical introduced that itsSelf-developed LomaPulse® Pulsed Electric FieldXiaoFinancial ProductsHigh-voltage pulsed electric field energy, capable of achieving myocardial-selective ablation, is employed to avoid damage to normal tissues surrounding the lesion site. Meanwhile, Zhouling Medical hasUnique InnovationofCatheter DesignTechnology, Self-Learning Detection Technology, and Multimodal Polarization Fusion Ablation TechnologyApplied to the field of atrial fibrillation treatment, it will further improve the efficiency and success rate of ablation procedures.
In the atrial fibrillation (AF) ablation market, the volume of electrophysiology procedures for AF in China has grown from approximately 10,000 cases in 2011 to around 100,000 cases in 2021, representing a tenfold increase over the decade.
We anticipate that as population aging intensifies, the number of newly diagnosed atrial fibrillation (AF) patients increases, and patient health awareness strengthens, the volume of AF electrophysiology procedures will continue to grow, driving expansion in the market size for AF ablation.
Based on this, the pulsed field ablation product developed by Zhouling Medical, as an innovative treatment option with lower risk and fewer complications, will also have greater opportunities for development.
Data shows that Zhouling Medical, the developer of this pulsed electric field ablation product, is aAn R&D-driven innovative medical device company dedicated to providing high-quality medical devices to patients in China and worldwide for the treatment of neurological, cardiovascular and cerebrovascular disorders, as well as other life-threatening critical diseases.
Zhouling Medical officially commenced operations in 2021 and completed its tens-of-millions-yuan Pre-A financing round, led by Shunwei Capital, at the end of that year. Currently, Zhouling Medical has established a comprehensive electrophysiology equipment system solution through independent R&D and collaborative development. Meanwhile, the company has also built a multi-pipeline portfolio spanning neurophysiology devices, cardiac electrophysiology devices, and other major specialty medical equipment for areas such as oncology and cancer care.
From 2021 to June 2022, Zhouling Medical not only advanced its pulsed field ablation product through R&D completion, design finalization, and enrollment of the first patient in clinical trials, but also expanded its portfolio with multiple additional product lines.
The reason Zhoulun Medical has been able to achieve such remarkable accomplishments in a short period is due to its strong technical team. It is reported that the core members of Zhoulun Medical’s R&D team are returnees from the United States and Germany, with decades of development and research experience in the field of medical devices. In addition to its robust R&D team, Zhoulun Medical has established strategic collaborations with leading domestic and international research institutions to jointly drive innovative research and development.
Meanwhile, as an R&D-driven innovative enterprise, Zhouling Medical established its R&D center in 2021, building foundational technology and industrialization platforms. The company has fully mastered and achieved independent research and development of core technologies, including mapping architecture, electrical architecture, software architecture, complex algorithms, and scanning imaging systems.
Zhouling Medical stated, “The company focuses on the R&D, clinical translation, scaled manufacturing, and commercialization of first-in-class and best-in-class medical devices. In the future, it will develop more innovative products to address urgent unmet clinical needs.”
Expert Profile：
Prof. Zhang Zhihui
Professor Zhang Zhihui isMedicineDr.、Prof.、Chief Physician、Ph.D. Supervisor, Central South University、Director of the Atrial Fibrillation Center, Director of the Heart Failure Center, and Mentor at the National Health Commission’s Interventional Training Base for Cardiac Arrhythmias, The Third Xiangya Hospital of Central South University.Standing Committee Member of the Young and Middle-aged Electrophysiology Experts Committee under the Heart Rhythmology Professional Committee of the Chinese Medical Doctor Association, National Committee Member of the Heart Rhythmology Professional Committee of the Chinese Medical Doctor Association, and Committee Member of the Atrial Fibrillation Working Group under the Pacing and Electrophysiology Branch of the Chinese Medical Association. With over 20 years of experience in medical care, teaching, and scientific research in cardiovascular diseases, he is the founder of the disciplines of pacing and electrophysiology, interventional therapy for congenital heart disease, and arrhythmia specialization at the Third Xiangya Hospital of Central South University. He has been engaged in the diagnosis and treatment of cardiac interventions for nearly 20 years, possessing profound expertise in the management of complex arrhythmias, congenital heart disease, and refractory hypertension. Over the past decade, he has successfully performed nearly 7,000 various cardiac interventional procedures, including 2,000 radiofrequency ablation surgeries for atrial fibrillation. He has published more than 20 academic papers, presided over one project funded by the National Natural Science Foundation of China, participated in seven provincial and ministerial-level scientific research projects, and contributed to the compilation of five academic monographs.